Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

CP-690,550 5 mg

CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.

CP-690,550 10 mg

CP-690,550 10 mg tablet orally twice daily up to Month 6.

Placebo, Then CP-690,550 5 mg

Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.

Placebo, Then CP-690,550 10 mg

Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS population. Participants with at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint were included. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

Reporting Groups

Description

CP-690,550 5 mg

CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.

CP-690,550 10 mg

CP-690,550 10 mg tablet orally twice daily up to Month 6.

Placebo

Matching placebo tablet orally twice daily up to Month 3.

Measured Values

CP-690,550 5 mg

CP-690,550 10 mg

Placebo

Number of Participants Analyzed
[units: participants]

236

239

120

Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
[units: units on a scale]Mean ± Standard Deviation

Baseline:Seen any doctor(n=236,239,119)

1.19
± 0.39

1.15
± 0.36

1.17
± 0.38

Baseline:Treated in emergency room(n=236,239,120)

1.94
± 0.23

1.92
± 0.26

1.92
± 0.28

Baseline:Admitted for overnight stay (n=13,18,10)

0.15
± 0.55

0.17
± 0.51

0.20
± 0.63

Baseline:Hospitalization(n=236,239,120)

1.94
± 0.24

1.92
± 0.27

1.94
± 0.24

Baseline:Outpatient surgery(n=236,239,120

1.97
± 0.16

1.95
± 0.21

1.98
± 0.16

Baseline:Non-study diagnostic test(n=235,239,120)

1.83
± 0.38

1.78
± 0.41

1.83
± 0.37

Baseline:In nursing home(n=236,239,120)

1.98
± 0.13

1.99
± 0.09

1.99
± 0.09

Baseline:Home healthcare services(n=235,239,119)

1.99
± 0.09

1.98
± 0.13

1.99
± 0.09

Baseline:Required aids/devices(n=236,239,119)

1.84
± 0.37

1.87
± 0.34

1.83
± 0.38

Baseline:Non-medical practitioner(n=236,239,120)

1.97
± 0.18

1.99
± 0.09

1.98
± 0.13

Baseline:Currently employed(n=236,239,120)

1.69
± 0.46

1.64
± 0.48

1.64
± 0.48

Baseline:Feel well enough to work(n=111,90,57)

1.86
± 0.35

1.83
± 0.37

1.86
± 0.35

Baseline:Unable to work due to RA(n=111,93,59)

1.37
± 0.48

1.29
± 0.46

1.41
± 0.50

Baseline:Lost job/retired early(n=110,92,58)

1.61
± 0.49

1.55
± 0.50

1.55
± 0.50

Baseline:Work disabled due to RA(n=111,91,58)

1.54
± 0.50

1.48
± 0.50

1.52
± 0.50

Baseline:Retired(n=116,99,59)

1.57
± 0.50

1.57
± 0.50

1.49
± 0.50

Baseline:Sick leave due to RA(n=191,202,99)

1.82
± 0.38

1.83
± 0.38

1.74
± 0.44

Baseline:Performed part time work(n=192,202,98)

1.89
± 0.31

1.87
± 0.34

1.88
± 0.33

Baseline:Performed paid work(n=191,204,99)

1.64
± 0.48

1.66
± 0.48

1.62
± 0.49

Baseline:Unable to do chores(n=235,238,118)

1.36
± 0.48

1.32
± 0.47

1.30
± 0.46

Baseline:Chores by housekeeper(n=235,239,119)

1.86
± 0.35

1.82
± 0.39

1.81
± 0.40

Baseline:Chores by family/friends(n=235,239,118)

1.40
± 0.49

1.44
± 0.50

1.29
± 0.45

Month 3:Seen any doctor(n=235,228,109)

1.42
± 0.49

1.41
± 0.49

1.39
± 0.49

Month 3:Treated in emergency room(n=236,229,109)

1.94
± 0.24

1.94
± 0.24

1.93
± 0.26

Month 3:Admitted for overnight stay (n=14,14,8)

0.29
± 0.61

0.43
± 0.65

0.50
± 0.93

Month 3:Hospitalization(n=236,228,109)

1.99
± 0.09

1.97
± 0.16

1.98
± 0.13

Month 3:Outpatient surgery(n=236,229,109)

1.97
± 0.17

1.98
± 0.15

1.98
± 0.13

Month 3: Non-study diagnostic test(n=236,228,109)

1.87
± 0.33

1.88
± 0.32

1.87
± 0.34

Month 3: In nursing home(n=236,229,109)

2.00
± 0.00

2.00
± 0.07

1.99
± 0.10

Month 3: Home healthcare services(n=236,228,108)

1.99
± 0.09

2.00
± 0.00

1.99
± 0.10

Month 3: Required aids/devices(n=235,228,109)

1.89
± 0.32

1.91
± 0.28

1.87
± 0.34

Month 3: Non-medical practitioner(n=236,229,109)

1.98
± 0.13

2.00
± 0.07

2.00
± 0.00

Month 3: Currently employed(n=236,228,109)

1.71
± 0.45

1.65
± 0.48

1.62
± 0.49

Month 3: Feel well enough to work(n=108,93,50)

1.72
± 0.45

1.69
± 0.47

1.86
± 0.35

Month 3: Unable to work due to RA(n=107,98,52)

1.51
± 0.50

1.48
± 0.50

1.35
± 0.48

Month 3: Lost job/retired early(n=107,92,49)

1.68
± 0.47

1.70
± 0.46

1.59
± 0.50

Month 3: Work disabled due to RA(n=109,92,49)

1.57
± 0.50

1.62
± 0.49

1.47
± 0.50

Month 3: Retired(n=115,107,51)

1.52
± 0.50

1.51
± 0.50

1.53
± 0.50

Month 3: Sick leave due to RA(n=180,183,88)

1.93
± 0.26

1.91
± 0.29

1.89
± 0.32

Month 3: Performed part time work(n=181,180,88)

1.94
± 0.23

1.94
± 0.24

1.90
± 0.30

Month 3: Performed paid work(n=179,184,88)

1.75
± 0.44

1.76
± 0.43

1.65
± 0.48

Month 3: Unable to do chores(n=231,227,107)

1.60
± 0.49

1.63
± 0.49

1.39
± 0.49

Month 3: Chores by housekeeper(n=235,229,108)

1.88
± 0.32

1.92
± 0.28

1.79
± 0.41

Month 3: Chores by family/friends(n=234,229,108)

1.65
± 0.48

1.64
± 0.48

1.49
± 0.50

No statistical analysis provided for Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.